Parkell 自粘性水泥
K号: K210259 · 2022-01-20
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决定日期2022-01-20
产品代码EMA
咨询委员会DE
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决定实质等同
器械摘要
Parkell Self-Adhesive Cement is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 2022-01-20 under 510(k) number K210259. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Parkell Self-Adhesive Cement?
Parkell Self-Adhesive Cement is a medical device that received FDA 510(k) clearance on 2022-01-20. The listed applicant is Parkell, Inc.. The 510(k) number is K210259.
When did Parkell Self-Adhesive Cement receive FDA 510(k) clearance?
Parkell Self-Adhesive Cement received FDA 510(k) clearance on 2022-01-20, under 510(k) number K210259.
Who is the listed applicant for Parkell Self-Adhesive Cement?
The FDA 510(k) record lists Parkell, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Parkell Self-Adhesive Cement?
The FDA product code for Parkell Self-Adhesive Cement is EMA.
相关临床试验
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列明Parkell, Inc.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：EMA）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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